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The goal of this clinical trial is to determine the clinical effectiveness of a Chronic Care Model (CCM) named Risk Assessment and Management Program on Knee OA (RAMP-Knee OA) in adults with knee Osteoarthritis (Knee OA) at 52 weeks.
Participants will be screened for eligibility to participate. After confirming eligibility, participants will complete the baseline assessment and be randomized into one of the following groups (n=114 for each group):
Outcomes will be measured at baseline, week 16, week 32, and week 52.
The goal of this clinical trial is to determine the clinical effectiveness of a Chronic Care Model (CCM) named Risk Assessment and Management Program on Knee OA (RAMP-Knee OA) in adults with knee Osteoarthritis (Knee OA) at 52 weeks. RAMP-knee OA is designed based on the validated framework of CCM, which identifies six important components including self-management support, clinical information systems, delivery system redesign, decision support, health care organization, and community resources.
The main questions the study aims to answer are:
In comparison with people undergoing usual care, whether:
Participants will be screened for eligibility to participate. After confirming eligibility, participants will complete the baseline assessment and be randomized into one of the following groups (n=114 for each group):
Outcomes will be measured at baseline, week 16, week 32, and week 52. Demographic data and knee pain duration will be collected at baseline assessment. Outcomes to measure include the severity of knee pain, physical function, level of physical activity, self-efficacy, level of anxiety and depression, insomnia, loneliness, health-related quality of life, and lower limb muscle mass. The use of co-intervention, analgesics, and other over-the-counter drugs will be recorded.
The baseline characteristics of the two groups will be compared using the independent samples t-test or the Mann-Whitney test for continuous variables and chi-square test for categorical variables.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAMP Knee OA | Experimental | Patients allocated to the intervention group will continue their "usual care" at the GOPCs, plus enrolment into the RAMP-Knee OA program. |
|
| Usual Care group | No Intervention | Patients allocated to the usual care arm will continue receiving their "usual care" at the GOPCs without any additional intervention. "Usual care" typically refers to the established and commonly provided treatments, interventions, and practices that patients would receive in routine clinical practice for their particular condition or disease. For GOPCs in Hong Kong, the follow-up period for all chronic diseases is typically every 4 months. Each consultation at GOPC has an average duration of 3-5 minutes, during which physicians will address all chronic diseases, including knee OA. Physicians may provide brief healthcare advice, prescribe chronic medications and analgesics if necessary, and refer patients to physiotherapy if indicated. The management approach for knee OA and other chronic diseases will be solely at the discretion of the attending physicians. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risk assessment and Management Programme - Knee Osteoarthritis | Behavioral | (i) Arthritis education: Topics will cover the 21 key messages identified in International Consensus List of Essential Statements for Osteoarthritis "What Do People With Knee or Hip Osteoarthritis Need to Know" (ii) Structured land-based exercise: We have selected strengthening, flexibility training (stretching), and aerobic exercise as our key components because they are most applicable in primary care settings. (iii) Weight Management: Weight management will be offered for participants with a BMI ≥ 23 kg/m2. (iv) Counselling support for psychosocial health: counselling support will be provided for those with mild to moderate anxiety and depression, insomnia and loneliness identified in the risk assessment. (v) Dietary advice: Online dietary education for musculoskeletal health (with reference to local context) will be provided. The dietitian will also provide support regarding specific dietary advice on weight management. |
| Measure | Description | Time Frame |
|---|---|---|
| Knee pain | Knee pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Baseline, week 16, week 32, week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Function | Physical function measured by WOMAC function subscale | Baseline, week 16, week 32, week 52 |
| Physical function | Physical function measured by 30-second chair and stand performance test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Regina Wing Shan SIT, M.D. | Jockey Club School of Public Health and Primary Care, Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lek Yuen GOPC | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41629997 | Derived | Sit RW, Yip BH, Choi SY, Wong MC, Law SW, Lam CY, Hunter D, Wong SY. Risk Assessment and Management Program (RAMP) on knee osteoarthritis in primary care-a one-year pragmatic randomized controlled trial. Trials. 2026 Feb 3;27(1):187. doi: 10.1186/s13063-026-09469-x. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D018570 | Risk Assessment |
| ID | Term |
|---|---|
| D012306 | Risk |
| D011336 | Probability |
| D013223 | Statistics as Topic |
| D004812 | Epidemiologic Methods |
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The study is a 52-week, two-arm, parallel, doubled-blinded randomized clinical trial, evaluating the clinical efficacy of RAMP-Knee OA (N=114) versus usual care (N=114) on self-reported knee pain and other secondary outcomes.
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All data collection will be performed by trained research assistants blinded to the allocation status of the patients, and statistician will analyse data without referring to allocation information.
|
| Baseline, week 16, week 32, week 52 |
| Lower limb muscle mass | Lower limb muscle mass measured by bio-impedance analysis | Baseline, week 16, week 32, week 52 |
| Level of physical activity | Level of physical activity measured by Chinese International Physical Activity Questionnaire (Short form) | Baseline, week 16, week 32, week 52 |
| Self-Management efficacy | Self-management efficacy measure by Pain-Self Efficacy questionnaire | Baseline, week 16, week 32, week 52 |
| Level of Anxiety | Anxiety measured by Generalized Anxiety Disorder -7 | Baseline, week 16, week 32, week 52 |
| Level of Depression | Depression measured by Patient Health Questionnaire -9 | Baseline, week 16, week 32, week 52 |
| Insomnia | Insomnia measured by 7 item Insomnia Severity Index | Baseline, week 16, week 32, week 52 |
| Loneliness | Loneliness measured by 6 item De Jong Gierveld Loneliness Scale | Baseline, week 16, week 32, week 52 |
| Health related Quality of Life | Health related Quality of life measured by Euroquol- 5D-5L | Baseline, week 16, week 32, week 52 |
| Demographic data | Demographic data such as height, weight, BMI, age, sex, knee pain duration, chronic comorbid conditions, chronic medications | Baseline |
| D012216 |
| Rheumatic Diseases |
| D008919 |
| Investigative Techniques |
| D012308 | Risk Management |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |